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CIN-107 for High Blood Pressure (HALO Trial)

Phase 2
Waitlist Available
Research Sponsored by CinCor Pharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

HALO Trial Summary

This is a Phase 2, randomized, multicenter study to evaluate the efficacy and safety of multiple dose strengths of baxdrostat (also called CIN-107) in the treatment of patients with uncontrolled hypertension. The primary objective was to demonstrate that treatment with baxdrostat for 8 weeks would lower the systolic blood pressure (SBP) in patients who were hypertensive despite taking one or two anti-hypertensive medications. Participants were assigned to take placebo or baxdrostat once per day for 8 weeks while they continued taking the regular anti-hypertensive medications. At the end of the 8-week period, qualified patients could participate in Part II of the study and receive 2 mg baxdrostat for 4 weeks while they discontinued taking the background anti-hypertensive medication.

Eligible Conditions
  • High Blood Pressure

HALO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Mean Seated Systolic BP (SBP)
Secondary outcome measures
Change From Baseline in 24-hour Serum Aldosterone
Change From Baseline in 24-hour Serum Renin
Change From Baseline in 24-hour Urine Aldosterone
+3 more

Side effects data

From 2022 Phase 2 trial • 275 Patients • NCT04519658
4%
Urinary tract infection
3%
Hyperkalaemia
1%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Safety Population 0.5mg
Safety Population 1mg
Safety Population 2mg
Safety Population Placebo

HALO Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: CIN-107 2 mgExperimental Treatment1 Intervention
Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient may remain on CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks or withdraw study participation depending on BP control
Group II: CIN-107 1 mgExperimental Treatment1 Intervention
Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks
Group III: CIN-107 0.5 mgExperimental Treatment1 Intervention
Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2 mg) and discontinue their background antihypertensive agent(s) for 4 weeks
Group IV: PlaceboPlacebo Group1 Intervention
Remain on background anti-hypersensitive regimen for 8 weeks. After 8 weeks, patient will receive the highest dose of CIN-107 (2mg) and discontinue their background antihypertensive agent(s) for 4 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CIN-107
2020
Completed Phase 2
~820

Find a Location

Who is running the clinical trial?

CinCor Pharma, Inc.Lead Sponsor
11 Previous Clinical Trials
858 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
California
Arizona
How old are they?
18 - 65
What site did they apply to?
CinCor Site 35
CinCor Site 36
What portion of applicants met pre-screening criteria?
Met criteria
~75 spots leftby Apr 2025